Background Infliximab is a chimeric, monoclonal antibody against tumour necrosis factor (TNF) alpha, recently developed to complement methotrexate therapy in RA patients with a less than optimal response to treatment. To date it has only been studied in clinical trials.
Objectives To describe referral patterns, patient response to treatment, and adverse events in a cohort of RA patients treated with infliximab in a real world setting.
Methods Patients who had received their first dose of infliximab between 1/00 and 6/00 were included to ensure the possibility of at least 6 months of drug exposure. We evaluated patients at baseline, and followed them prospectively every 2 months for a total of 6 months. Patients completed several questionnaires regarding RA history, treatment, and disease activity (HAQ, pain, fatigue, tender and swollen joint counts) at each infusion. All subjects were contacted between infusions for reporting of side effects.
Results 36 patients were treated with infliximab between January 1 – June 30, 2000 (female n = 33, mean age = 63 ± 12.9 y, disease duration = 15.3 ± 10.2 y). They had previously failed an average of 3 DMARDs. 24 patients were on oral steroids at baseline. 16 patients received infliximab without concurrent MTX. 12 of 36 patients discontinued treatment before 6 months. Discontinuation reasons were inadequate response (n = 5), repeated episodes of dyspnea (n = 3), asthma (n = 1), chest tightness (n = 1), phlebitis (n = 1), and patient noncompliance (n = 1). Table 1 shows individual measures of disease activity in 24 patients who completed 6 months of infliximab. We detected a significant improvement in HAQ scores, and trends toward improvement in pain scores and tender joint counts. HAQ scores improved in 19/24, stiffness in 14/24, pain in 13/24, fatigue in 13/24, tender joint counts in 13/24 and swollen joints in 15/24 of patients. Since initiating infliximab therapy, of the 36 patients receiving 198 infusions, 18 patients reported a total of 33 adverse events (headaches n = 8, nausea n = 2, abdominal pain n = 2, chest pain n = 1, chills n = 2, dyspnea n = 3, myalgias n = 3, pruritis n = 4, fatigue n = 3, and rash n = 5).
Conclusion Infliximab is often used in more difficult RA patients (older, long-standing RA, multiple DMARD failures). This referral pattern may explain the increased incidence of adverse events and suboptimal clinical response noted in our cohort. However, our results suggest a trend towards rapid, clinically important improvement in measures of disease activity. Ongoing follow-up of this growing group of patients will provide necessary information regarding the appropriate role of infliximab in the treatment of RA.
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